Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:50 AM
Study NCT ID:
NCT07403760
Status:
RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in SF-36 Total Score', 'timeFrame': 'Baseline, 6 months', 'description': 'Difference in the change of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) total score from baseline to 6 months between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Change in AFEQT Score', 'timeFrame': 'Baseline, 6 months', 'description': 'Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score'}, {'measure': 'Change in Clinical Frailty Scale (CFS) Score', 'timeFrame': 'Baseline, 6 months', 'description': 'Change in frailty status assessed by CFS'}, {'measure': 'Change in Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Change in NT-proBNP level', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Change in 6-Minute Walk Distance (6MWT)', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Freedom from Atrial Arrhythmias', 'timeFrame': '6 months', 'description': 'Absence of atrial fibrillation, atrial flutter, or atrial tachycardia recorded by ECG, Holter, or patch monitor after a 30-day blanking period.'}, {'measure': 'Incidence of Composite Cardiovascular Outcome', 'timeFrame': '6 months', 'description': 'Composite of all-cause death, stroke or systemic embolism, myocardial infarction, major bleeding, and heart failure hospitalization/emergency visits.'}, {'measure': 'Healthcare Resource Utilization', 'timeFrame': '6 months', 'description': 'Number of emergency room visits and unplanned hospitalizations'}, {'measure': 'Serious Adverse Events', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['catheter ablation', 'very elderly', 'quality of life'], 'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'The WISER-AF trial is a multicenter, double-blind, sham-controlled, randomized controlled trial. It aims to evaluate the efficacy and safety of catheter ablation compared to a sham procedure in improving the quality of life (SF-36 score) in very elderly patients (aged ≥80 years) with symptomatic atrial fibrillation over a 6-month follow-up period.', 'detailedDescription': 'Atrial fibrillation (AF) prevalence increases with age, posing significant challenges in the very elderly (≥80 years). While catheter ablation is an established treatment for general AF patients, its efficacy in improving quality of life (QoL) in the very elderly remains underrepresented in previous trials. The WISER-AF trial is designed to fill this evidence gap. The study will enroll 182 symptomatic AF patients aged ≥80 years in China. Patients will be randomized 1:1 to undergo either pulsed field ablation (PFA) or a sham procedure. To ensure blinding, all patients will wear eye masks and headphones during the procedure. The sham group will receive phrenic nerve stimulation to mimic the sensation of ablation without delivering therapeutic energy. The primary endpoint is the change in the SF-36 total score from baseline to 6 months. Secondary endpoints include changes in AFEQT score, Clinical Frailty Scale (CFS), LVEF, NT-proBNP, 6-minute walk distance, and cardiovascular events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 80 years.\n2. Documented paroxysmal or persistent atrial fibrillation by ECG or Holter within 6 months prior to enrollment.\n3. Symptomatic AF (including palpitations, chest tightness, fatigue, dizziness, blackouts, dyspnea).\n4. Voluntary participation and signed informed consent.\n\nExclusion Criteria:\n\n1. NYHA Class IV heart failure.\n2. Acute myocardial infarction, cardiac surgery, or PCI within the past 1 year.\n3. Long-standing persistent AF (duration \\> 1 year).\n4. Left atrial anteroposterior diameter \\> 6 cm.\n5. History of prior AF ablation.\n6. AF secondary to reversible causes (e.g., post-surgery, infection, hyperthyroidism).\n7. Severe mitral stenosis.\n8. Moderate to severe hepatic failure (Child-Pugh B-C).\n9. Renal failure stage 4-5 (eGFR \\<30 ml/min/1.73m2) or continuous dialysis.\n10. Inability to cooperate due to dementia or severe mental disorder.\n11. Presence of left atrial thrombus.\n12. Prior Left Atrial Appendage Occlusion (LAAO).\n13. Contraindication to anticoagulation.\n14. Life expectancy \\< 1 year.'}, 'identificationModule': {'nctId': 'NCT07403760', 'acronym': 'WISER-AF', 'briefTitle': 'Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Wellbeing and Survival Improvement With Event Reduction by Ablation for Atrial Fibrillation in the Very Elderly (WISER-AF)', 'orgStudyIdInfo': {'id': 'KS202607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Catheter Ablation Group', 'interventionNames': ['Procedure: Catheter Ablation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Control Group', 'interventionNames': ['Procedure: Sham Control']}], 'interventions': [{'name': 'Catheter Ablation', 'type': 'PROCEDURE', 'description': 'Patients undergo PVI (for paroxysmal AF) or PVI +linear ablation+EI-VOM(for persistent AF) using pulsed field ablation catheters. All patients will wear eye masks and headphones with music during the procedure.', 'armGroupLabels': ['Catheter Ablation Group']}, {'name': 'Sham Control', 'type': 'PROCEDURE', 'description': 'Patients undergo femoral vein puncture and catheter placement. Phrenic nerve stimulation is performed to mimic procedural sensations. No ablation energy is delivered. All patients will wear eye masks and headphones with music during the procedure. Patients remain in the lab for at least 80 minutes.', 'armGroupLabels': ['Sham Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu He, PhD.', 'role': 'CONTACT', 'email': 'theliu@139.com', 'phone': '+86 13810720787'}, {'name': 'Changsheng Ma, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ning Zhou, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital, Capital Medical University, Beijing, China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liu He, PhD', 'role': 'CONTACT', 'email': 'theliu@139.com', 'phone': '+86 13810720787'}], 'overallOfficials': [{'name': 'Changsheng Ma, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}, {'name': 'Ning Zhou, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}